Engineer III

About This Role

The Engineer III, Automation maintains and troubleshoots all process control system hardware and software (DeltaV DCS system) in support of the biopharmaceutical manufacturing process. Leads pre-planning change control meeting and facilitates change control approval process for new control strategies in support of new products and processes. Creates software life cycle design/validation documents, executes software validation, supports install/commissioning/manufacturing release of software changes. Supports tech transfers, SME lead on capital automation projects and performs Responsible Engineering (RE) duties across multiple Manufacturing Unit Operations. Troubleshoots process control systems and supports manufacturing operations through an 24/7 on-call rotation with some assistance.

What You'll Do

• Manage change controls and configure software for process improvements or new equipment. This includes configuring existing code and developing new control strategies for new and existing processes introduced into the facilities.
• Validate and test software. Create and execute software testing scripts utilizing GAMP 5 principles and internal compliance procedures.
• Troubleshoot software and hardware that comprises the DeltaV systems.
• Review and approve process automation reports (PARs)
• Lead automation functional change control planning meetings.
• Manage variable project arrival rate and prioritize these projects to maintain uninterrupted manufacturing operations.

Who You Are

You have a combination of technical expertise, strong problem-solving skills, and effective communication abilities. You are adept at maintaining and troubleshooting process control systems while also demonstrating leadership in change control processes and software validation. Additionally, you are capable of managing various engineering projects and allocating tasks accordingly.

Requirements

• Bachelors Degree in a relevant scientific/or technical discipline.
• 2-4 years relevant experience.
• Comprehensive knowledge of DeltaV distributed control system.
• Experience implementing DeltaV software changes and supporting within production environments
• Working knowledge of cGMP and GAMP guidelines.

Preferred Qualifications

• Biotechnology or batch pharmaceutical experience production experience.
• Experience in Biotechnology Manufacturing specific areas: Cell Culture, Chromatography, Centrifugation, Ultrafiltration, CIP\SIP.